FDA Grants Priority Review to Keytruda for Relapsed or Refractory Classical Hodgkin’s Lymphoma

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FDA Grants Priority Review to Keytruda for Relapsed or Refractory Classical Hodgkin’s Lymphoma
August 05, 2020August 5, 2020
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The U.S. Food and Drug Administration (FDA) has accepted and given priority review to Merck‘s application requesting the approval of Keytruda (pembrolizumab) as a second-line treatment for adults with relapsed or refractory classical Hodgkin’s lymphoma (cHL). The supplemental biologics license application was based on data from the Phase 3 KEYNOTE-204 clinical trial (NCT02684292), in which Keytruda significantly extended life without disease worsening compared with standard Adcetris (brentuximab vedotin). The agency has set a Prescription Drug User Fee…

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